Study of ZGGS15 in Patients With Advanced Solid Tumors

Trial Title: Study of ZGGS15 in Patients With Advanced Solid Tumors

NCT ID: NCT05864573

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: ZGGS15
Description: ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks.
Arm group label: ZGGS15

Summary: This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Fully understand the study and voluntarily sign the informed consent form; - Male or female, 18-70 years of age; - Histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed; - Must have at least 1 measurable lesion per RECIST v1.1; - Eastern Cooperative Oncology Group performance status of 0 or 1; - Life expectancy ≥ 3 months; - All adverse events from prior treatment have either returned to baseline or CTCAE v5.0≤Grade 1; - Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. Exclusion Criteria: - Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of the central nervous system (CNS) metastases； - Uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study; - The main organ function meets any of the following criteria within 7 days prior to treatment: - Hematological function: absolute neutrophil count (ANC) < 1.5 × 10^9/L, platelet (PLT) < 75 × 10^9/L, or hemoglobin (Hb) < 100 g/L; - Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), ALT and AST ≥ 5×ULN for patients with liver metastases; total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30 g/L; - Blood cholesterol > 300 mg/dL or > 7.75 mmol/L; - Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min; - International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5×ULN; - Any other malignancy within 5 years; - Abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments; - History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis; - Previous immune checkpoint inhibitors induced ≥ Grade 2 immune-related adverse reactions in vital organs, including but not limited to myocarditis and central nervous system toxicity; rapidly tumor progressed after previous PD-1 inhibitor treatment; - Interstitial lung disease, non-infectious pneumonitis, and radiation-induced pneumonia with symptoms and/or requiring steroids for treatment; - Received prior allogeneic stem cell transplantation or solid organ transplantation; - Active infection within 1 week before the first administration currently requires systemic anti-infective therapy; - Known allergy to other mAbs or any antibody excipient, severe allergic reaction to humanized antibodies or fusion proteins, and history of anaphylactoid reaction or other hypersensitivity reactions; - Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.; - Patients were deemed unsuitable for participating in the study by the investigator for any reason.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Country: China

Status: Recruiting

Contact:
Last name: Ji Zhu

Start date: July 19, 2023

Completion date: August 2024

Lead sponsor:
Agency: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class: Industry

Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05864573